Exact Imaging Announces Health Canada Approval for its FusionVu™ Application for Micro-Ultrasound/MRI Fusion

Exact Imaging, the world’s leader in high resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, announced it has received Health Canada approval for its FusionVu™ application for micro-ultrasound/MRI fusion using the ExactVu high resolution micro-ultrasound system.

“We are excited to have received regulatory approval from Health Canada allowing our FusionVu application, a feature of our ExactVu micro-ultrasound system, to be commercially available in Canada,” says Randy AuCoin, Exact Imaging’s President and CEO. “The ExactVu micro-ultrasound system provides the highest real-time resolution for targeted prostate biopsies. Urologists who appreciate the benefit of MRI for select clinical cases, such as patients with repeat negative biopsies but with increasing risk indications, can now have the best of both worlds. They can leverage FusionVu to align the patient’s MRI with the live micro-ultrasound image to either perform Cognitive Assist™ or micro-ultrasound/MRI fusion-guided biopsies, all with the benefit of the 70-micron resolution of micro-ultrasound”.

The ExactVu installed base is growing globally and rapidly and this approval allows Exact Imaging’s Canadian customers to now use the FusionVu application. FusionVu has already received its CE Mark, allowing commercial access in the European Union as well as its FDA 510(k) clearance enabling commercial access in the United States.

About Exact Imaging

Exact Imaging (www.exactimaging.com) is the world’s leader in high-resolution micro-ultrasound systems enabling real-time imaging and guided biopsies in the urological market for prostate cancer. Exact Imaging’s ExactVu™ micro-ultrasound platform operates at 29 MHz and enables a whole new level of resolution with the benefits of ease of use, affordability, and is an extension of the current urological workflow. Using the Exact Imaging platform, urologists are able to visualize areas of interest in the prostate and specifically target biopsies at those areas. For the minority of cases where MRI might assist (i.e., prior negative biopsies), the FusionVu™ micro-US/MRI fusion application operates on the ExactVu micro-ultrasound platform and facilitates MRI fusion-based targeting. The ExactVu micro-ultrasound system and FusionVu have received regulatory approval in the European Union (CE Mark), the United States (FDA 510(k)) and Canada (Health Canada medical device license).